PMA P860023S012

Device: BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P860023
Supplement: S012
Product code: LPN
Decision date: 1997-07-03
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.

Current openFDA PMA Record

Device: BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
Applicant: Bausch & Lomb, Inc.
PMA number: P860023
Supplement: S012
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-07-03
Decision code: APPR
Date received: 1996-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.